Begg C B
Bull Cancer. 1987;74(2):197-203.
The impact of changes in the source population of patients for cancer clinical trials in the USA is considered. The first change, which has already taken place, is the recent trend of including patients treated of community hospitals in cooperative group and other randomized trials. This change was designed to augment accrual to studies, and to disseminate state-of-the-art information on patient care. The change has been shown to be a successful one, with community hospitals providing high quality participation in the trials. In addition, the research protocols have been seen to influence the care of many patients treated off-protocol. The inclusion of community hospitals in the trials clarifies our understanding of the generalizability of the results of the trials. The issue of generalizability is, however, obscured by the fact that the great majority of cancer patients are not treated on protocols. Indeed most of them are ineligible for protocols. The rationale for strict eligibility is unclear in many cases, and its use greatly reduces accrual and casts doubt on the generalizability of results. In the future, more care should be paid to the selection of the source population for clinical trials.
本文探讨了美国癌症临床试验患者源人群变化所产生的影响。第一个已经发生的变化是，近期在合作组试验及其他随机试验中纳入社区医院治疗患者的趋势。这一变化旨在增加研究的入组人数，并传播有关患者护理的最新信息。事实证明这一变化是成功的，社区医院在试验中提供了高质量的参与。此外，研究方案已被视为对许多未按方案治疗的患者的护理产生影响。将社区医院纳入试验，有助于我们更清楚地了解试验结果的可推广性。然而，由于绝大多数癌症患者并非按方案接受治疗，可推广性问题变得模糊不清。实际上，他们中的大多数不符合方案要求。在许多情况下，严格的入选标准的基本原理并不明确，其使用极大地减少了入组人数，并对结果的可推广性产生怀疑。未来，应更加关注临床试验源人群的选择。
